VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100— 510(k) K853961

Substantially Equivalent

Visitec Co.

FDA 510(k) clearance K853961 for VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100, Substantially Equivalent on 1985-12-13. Applicant: Visitec Co..

Clearance details

Applicant: Visitec Co.
Product code: Code HQE
Advisory panel: Ophthalmic
Date received: 1985-09-25
Decision date: 1985-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sarasota, FL, US

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Adverse events under product code HQE

product code HQE

Injury: 156
Malfunction: 565
Total: 721

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.